Before 5 months of the party secretary and deputy director of the State Administration of Market Supervision and Administration, Bi Jingquan, 63, unexpectedly left the scene.On the evening of August 16, the vaccine case that shocked the country ushered in accountability.According to the decision of the Standing Committee of the Political Bureau of the CPC Central Committee, many senior officials at the provincial and ministerial levels were punished and Bi Jingquan, who was required to resign, was the only official official.And he is also the team leader of the investigation team of the China Institute of China, and is considered by the industry to be the director of the drug regulatory bureau with the best results over the years.
Changsheng Biotechnology Co., Ltd. (Andnbsp; 002680.szandnbsp;, ST Changsheng, hereinafter referred to as Changsheng Bio) The vaccine case was exposed on July 15.In fact, the rabies vaccine produced by the sample Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as Changchun Changsheng) were found to have illegal and illegal acts such as fake production records.Bai Bai -breaking vaccines with unqualified costs flow into Shandong and other places, becoming the target of public opinion.
After 1 month of fermentation in the public opinion field, the report on the Changchun Changsheng survey reported under the prevailing of the Supreme Leader: the vaccine producer is profitable, violated national drug standards and the quality management specifications of drug production, compiles false production inspection records, local governments and regulatory supervisionThe department is out of duty, and the malfeasance of individual staff is a major case of serious violations of regulations and illegal production.
As the head of the pharmaceutical supervision department, Bi Jingquan finally couldn't blame it.Responsibility is to be responsible.But his blame resigned also made many people feel sorry.
Bi Jingquan is a native of Qing'an County, Heilongjiang Province. After receiving a bachelor's degree in economics at Peking University in 1982, he entered the State Price Bureau.He was the deputy director of the National Development and Reform Commission in 2006, and since 2008, he has been the Deputy Secretary -General of the State Council since 2008.In January 2015, before Bi Jingquan served as the former Director of the State Food and Drug Administration (CFDA) and the party secretary of the party group, he even did not even have any medical system work background.But with the launch of a series of reform measures, the outside world expressed high recognition of it.
Looking back on its reform measures in three years, most of the outside world described "Blackstorms, True Swords, Real Gun Andrdquo; and even known as the most stricter drug supervision in history.The food and drug supervision system has really entered the right track of scientific supervision.
Prior to this, the digital director and deputy director of the Chinese food and drug supervision system were involved in the corruption case, including Zheng Xiaoyin, the first CFDA director who was executed in 2007.In the accountability of the vaccine storm, the State Supervision Commission of the Central Commission for Discipline Inspection also conducted a review and investigation of the former Deputy Director of CFDA and the former deputy director of the Health and Family Planning Commission.
Systemic issues of vaccine supervision
In 2016, Shandong's illegal operation vaccine case was exposed. Bi Jingquan was also the former director of CFDA and the leader of the investigation team of the State Council.There were storms in the vaccine industry and were considered systemic problems.
For the State Drug Administration, which is in charge of drug safety, it has a significant responsibility from vaccine from inspection to circulation.Since the National Drug Administration announced on July 15 that the production process of Changchun Changsheng rabies vaccine was fraudulent, and there was a problem of insufficient cost of fermented Baibai vaccine, the national pharmaceutical supervision and management department was questioned by the inspection and supervision of the vaccine.
In fact, the problems of vaccine safety and effectiveness in recent years have emerged endlessly, which is not related to the production level of the entire industry.At the same time, a new trend has emerged in violation of laws and regulations.
The safety hazards of the production link are not a case.In 2009, the original State Food and Drug Administration disclosed that 7 batches of people produced by Hebei Folk Pharmaceutical Co., Ltd. and Jiangsu Yanshen Biotechnology Co., Ltd. are costly than rabies vaccine than national standards, involving the number of vaccines 215,800 branchesEssenceIn 2010, Jiangsu Yanshen Biotechnology Co., Ltd. acknowledged that it was unsatisfactory for the 4 batches of rabies vaccine produced in 2008, involving about 180,000 vaccines.
In 2013, Dalian Jingang Andi Biological Products Co., Ltd. deliberately falsified and added nucleic acid substances illegally in rabies vaccine, and was revoked to the GMP certificate.
And "From a longer historical perspective, we found that vaccine safety incidents have begun to concentrate on production in recent years, rather than traditional illegal operations and illegal vaccination. Anandrdquo; an expert who has been concerned about drug regulatory regulations for a long time told Caixin reporter to Caixin reporter.
The expert said that the turning point occurred in 2008 institutional reforms, canceling vertical management below the provincial provincial province and implementing graded management.
In this rabies vaccine incident, the State Drug Administration found this problem based on the report clues.And "Actually, vaccine safety supervision is heavy in daily life. It is not solved by limited flight inspections. Land management has made daily supervision power sink to the place.Disclosure. Andrdquo; The above experts told Caixin reporter.
As early as November 2017, Changsheng Bio was found to have no cost of Baibai's vaccine, but the punishment decision of the competent department of Jilin Province was not made until the incident.
On July 18, the Jilin Provincial Food and Drug Administration issued a decision on the administrative punishment of Changchun Changsheng, saying that the company's adsorption of cells without cells (batch number: 201605014-01)Yuan.The batch of vaccines were discovered in November 2017, and all sold out to the Shandong market with a total of 252,600.
In the latest investigation results disclosed by the State Council's investigation team, Changchun Changsheng produced a total of 499,800 undercurrent vaccines.Compared with the 252,600 uniquely announced by the Jilin Provincial Food and Drug Administration's penalty decision on July 20, 2018, nearly doubled.
At the same time, it was also found that Bai Bai's vaccine was not qualified. There was also a limited liability company of the Wuhan Biological Products Research Institute. The vaccine involved was 40,500, all of which were sold to Chongqing and Hebei.
On the evening of August 16, the Changchun Changsheng issue vaccine ushered in accountability, and local officials of Jilin Province were severely punished.Among them, Jin Yuhui, deputy governor of Jilin Province, was removed from office, Li Jinxiu, vice chairman of the CPPCC, ordered his resignation and Changchun Mayor Liu Changlong to resign. Jiang Zhiying, member of the Standing Committee of the Jilin Provincial Party Committee, made a deep inspection.
That night, the State Drug Administration held a cadre conference urgently, stating that it would profoundly reflect on learning, make every effort to do the follow -up work of vaccine disposal, strengthen the investigation of hidden risks, improve the long -term mechanism of vaccine drug supervision, and strengthen the construction of cadre teams.
A key question is that illegal and illegal acts in the field of vaccine are corporate cases or common phenomena in the industry?What will happen in the future?
Where does the reform of drug supervision go from
People in the industry are worried that after Bi Jingquan's job, the reform of the drug supervision system will usher in greater uncertainty and even go backwards.The reform of Bi Jingquan's administration to touch the industry's old pattern has faced greater resistance.
Why reform?At the establishment of the 11th Pharmacopoeia Committee in 2017, Bi Jingquan revealed his four -point cognition of the reality of drug supervision.First, the drug can be solved basically, but there is a gap in quality efficacy.Second, the problems of drug research and development, production and processing, and distribution are concentrated.
Third, the review and supervision forces are weak, and the personnel of supervision teams are seriously lacking.These three issues together lead to the backlog of drug registration, and the efficiency is low, which also constitutes the overall idea and direction of Bi Jingquan as the former CFDA director.
The approval of new drugs is the first focus of work after taking office.On July 31, 2015, the original CFDA issued "announcement of several policies on the problem of accommodation of drug registration applications", which was considered to be a long -term criticism system.
Immediately after 2015 and 2017, the "Opinions on Reforming the Approval System for Reform of the Medical Devices and Medical Devices", "Opinions on Deepening the Reform of the Review and Approval System of Review and Approval of Drugs and Encouraging the Innovation of Drug Medical Devices" were introduced.What will happen to supervision?
Where does the reform of drug supervision go from
People in the industry are worried that after Bi Jingquan's job, the reform of the drug supervision system will usher in greater uncertainty and even go backwards.The reform of Bi Jingquan's administration to touch the industry's old pattern has faced greater resistance.
Why reform?At the establishment of the 11th Pharmacopoeia Committee in 2017, Bi Jingquan revealed his four -point cognition of the reality of drug supervision.First, the drug can be solved basically, but there is a gap in quality efficacy.Second, the problems of drug research and development, production and processing, and distribution are concentrated.
Third, the review and supervision forces are weak, and the personnel of supervision teams are seriously lacking.These three issues together lead to the backlog of drug registration, and the efficiency is low, which also constitutes the overall idea and direction of Bi Jingquan as the former CFDA director.
The approval of new drugs is the first focus of work after taking office.On July 31, 2015, the original CFDA issued "announcement of several policies on the problem of accommodation of drug registration applications", which was considered to be a long -term criticism system.
Immediately after 2015 and 2017, the "Opinions on Reforming the Approval System for Reform of the Medical Devices and Medical Devices", "Opinions on Deepening the Reform of the Review and Approval System of Review and Approval of Drugs and Encouraging the Innovation of Drug Medical Devices" were introduced.The quality of approval, solving backlogs, optimization services, encouraging research and creating new drugs have significant role, and the industry is well -received.
And "The general goal of reform is to integrate with andRDQUO;, in Bi Jingquan's eyes, the listing of new drugs must pursue and" global new Andrdquo;, and generic drugs must be consistent with the quality of the original drugs. The drug standards are mentioned "extreme importance andrdquo;Level.
After the main administration and drug supervision department, Bi Jingquan promoted the consistency evaluation of generic drugs that was almost stagnated before, and published the relevant technical guidance principles and policy planning documents densely.The oral solid institutional agent approved by the 1st day of the market should be completed by the end of 2018 by the end of 2018.
At that time, Shi Lichen, the person in charge of Beijing Dingchen Pharmaceutical Consultation, told Caixin reporter that this policy was great, which may lead to "except for more stable Chinese medicine companies, and chemicals will be reduced by half.
Andrdquo; At the same time, the upstream pharmaceutical auxiliary materials industry in the generic drug industry is also intensive. The "auxiliary materials filing system is about to be implemented, the industry's quasi -entry threshold will increase, the industrial upgrade will be accelerated, and the supervision and concentration of the auxiliary materials industry will be greatly improved.Chengdu Corporate President who has been doing medicine for more than ten years told Caixin reporter that "the auxiliary materials industry manufacturer will disappear at least half or more.Andrdquo;
A person from the General Administration of Food and Drug told Caixin reporter that and the "category, scope, and level of" generic drugs, and the current situation of China's low imitation, high, and chaotic dosage. ANDRDQUO;
Jia Ping, a part -time professor at the Law School of St. Mary University in the United States, believes that the Chinese government has proposed innovative drugs and generic drugs together, requiring generic drugs to make consistency evaluation, improve quality and effectiveness, and recognize the clinical trial data of eligible conditions abroad, promote the listing of new drugs to market, "If these three breakthroughs, we can make such a judgment: the eve of the Chinese pharmaceutical industry is on the eve of a fundamental change. Anandrdquo;
Since 2015, with the acceleration and approval of new drug reviews, the launch of the consistency evaluation of generic drugs, the system of pilot drug listing permit holders, formulate a series of measures such as clinical trial institutions and personnel, and promote the medical insurance support of innovative drugs.For the launch, the breadth and depth of the reform and depth of China's pharmaceutical supervision are continuously expanded. In Bi Jingquan's own words, "reform is not limited to review and approval, and gradually expands the comprehensive change of the drug supervision system Andrdquo;
And "He really did a lot of things during his reign, such as vigorously increasing the hand of CDE (Drug Review Center). In the past few years, Chinese drugs have been significantly accelerated, so that we are full of confidence.
Andrdquo; Minister of Pharmaceutical Policy, a multinational pharmaceutical company, told Caixin reporter that although Bi Jingquan's resignation ending was unavoidable due to the influence of "vaccine incident andrdquo;The company feels deep.Andrdquo; he said.
According to the "2017 Drug Review Report" issued by the original CFDA, the registration application for waiting for review has been reduced from nearly 22,000 pieces at the peak of 2015 to 4,000.
In the 2017 chemical drug innovation drug registration application, 149 varieties, an increase of 66%over 2016.Breakthrough progress has been made in the consistency evaluation work of generic drugs. As of now, a total of 5 batches of 57 drugs have passed consistency evaluations, and the original drug replacement of original drugs is speeding up.
In March of this year, the State Council has set off the eighth reform of institutional institutions since the reform and opening up.State Administration of Market Supervision and Management of Features.
Thanks to the outstanding performance of drug supervision in CFDA before, Bi Jingquan, 63, was pushed to the position of party secretary and deputy director. The outside world also looked forward to continuing his drug supervision reform storm in new positions.The true impact of the official earthquake after the vaccine incident on this problem is still observed.■
